BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 10182093 · Received June 22, 2020

    Report

    Report Number
    2182208-2020-01146
    Event Type
    Injury
    Date Received
    June 22, 2020
    Date of Event
    January 1, 2019
    Report Date
    June 22, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE:UNIQUE ABDOMINAL TWIDDLER SYNDROME JOURNAL OF ARRHYTHMIA. 2019; 35(1):142-144. 10.1002/JOA3.12133. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING AN IMPLANTABLE PULSE GENERATOR (IPG). THE AUTHORS DESCRIBED THAT SIX WEEKS POST IMPLANT THE PATIENT PRESENTED WITH AN ABDOMINAL PROTRUSION AND INTERMITTENT PAIN AT THE POCKET SITE. REGARDLESS OF THE PATIENT¿S POSITION THE IPG ¿TOOK A SPONTANEOUS STAND UP POSITION IN THE ABDOMINAL POCKET.¿ PRIOR TO PRESENTING TO THE HOSPITAL THE PATIENT REPEATEDLY MANIPULATED THE DEVICE FROM THE PERPENDICULAR TO THE FLAT POSITION WITHIN THE POCKET. ADDITIONALLY, ABDOMINAL DISTENTION DUE TO CHRONIC CONSTIPATION AND INTESTINAL GAS LED THE IPG TO SPONTANEOUSLY RE-STAND IN A PERPENDICULAR POSITION. A POCKET REVISION WAS PERFORMED AND FOLLOWING THERE WAS RESOLUTION OF THE DEVICE ROTATION AND PAIN. THE DEVICE REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645905 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. ADDR06

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R